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iSy® ODSecure® Abutment
EUDAMEDClass IIb (EU MDR)
Ref P2273.4050Ref P2273.4010Ref P2273.4020
by ALTATEC GmbH
Identity
- Trade Name
- iSy® ODSecure® Abutment EUDAMED
- Device Name
- iSy® ODSecure® Abutment EUDAMED
- Model / Reference
- P2273.4050 EUDAMEDP2273.4010 EUDAMEDP2273.4020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099797021134 EUDAMED04099797021097 EUDAMED04099797021103 EUDAMED
- Basic UDI-DI
- 40997970001907000000000Q2 EUDAMED
- Secondary DI
- E219P227340501 EUDAMEDE219P227340101 EUDAMEDE219P227340201 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iSy® ODSecure® Abutment by ALTATEC GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40997970001907000000000Q2 | Class IIb | Active |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (3)
- EUDAMED c99d7883-7e31-4d3b-b803-9db583586786 61 fields · synced Jul 11, 2026
- EUDAMED e033b42e-7c52-4b26-9a10-f8968e50aa9a 61 fields · synced May 17, 2026
- EUDAMED 4d71dc9b-40d4-4cac-be33-b81f8ccf4e8b 61 fields · synced May 18, 2026